SCAI 2017
0900
Dr. Ajay Kirtane (@Ajaykirtane) spoke about the upcoming / ongoing Eclipse trial, which is starting to enroll.
Coronary calcium can make stent deployment more difficult, hinder full expansion, and deform stents. Use of atherectomy (using laser ablation, cutting balloon, rotational or orbital atherectomy) may help improve stent deployment, and reduce DES target lesion "failure".
The TWENTE and DUTCH PEERS studies showed worse early outcomes in patients with heavy coronary calcification
Prior randomized trials have not shown significant clinical differences in patients who underwent rotational atherectomy prior to DES placement (ROTAXUS). There was a significant difference in successful stent placement.
Despite having 2 atherectomy devices, <5% of all cases done in the US have atherectomy as part of the treatment.
The Eclipse trial, using the CSI orbital atherectomy device, is to be used in a randomized fashion to pre-treat calcified lesions prior to stent placement. Prior trials (predominantly safety and efficacy trials: ORBIT II) have shown it to be safe, but have been single arm trials.
Approximately 2000 patients will be randomized.
Many concerns regarding randomization would be whether or not operators would be willing to enroll patients with heavy calcification in a trial where they may not get atherectomy, or if they would be willing to use atherectomy in a patient in whom they might be able to successfully perform PCI without it.
Jeffrey M. Schussler, MD, FACC, FSCAI
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